NocturiaHARALDNCT04433897
Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women
An observational study of Nocturia, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Aim of this study was to observe The study was adjusted in two parts: PART 1 is a crossectional study in which the prevalance, risk factors and etiology of nocturia among postmenopausal women is assessed. PART 2 is a cohort study observing the impact of 10 different hormonal substitution therapies on nocturia. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nocturia
- What is being tested?
- Questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who are biochochemically confirmed to be postmenopausal.
Who may be able to join
- Women with postmenopausal symptoms (hot flushes, atrophy, ..)
- All women were 'early' postmenopausal stages +1a,+1b or +1c as defined by the 'Stages of Reproductive Aging Workshop' (STRAW) criteria
Who cannot join
- Intake of HRT on the moment of inclusion
- women with thyroid dysfunction
- women using antihypertensive agents
- women with a history of psychiatric or neurological disorders
- women with a history of alcohol or drug addiction.
Trial locations and contacts
1 site in 1 country.
Karel Everaert contact
Belgium1 site, 1 recruiting
- Recruiting
Department of Urology, Ghent University
Ghent, Oost-Vlaanderen, 9000
Kim Pauwaert, MD, +32 93321182, kim.pauwaert@uzgent.be
An-Sofie Goessaert, MD, PhD
About this study
Official title: Observing the Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women
Aim of this study was to observe
The study was adjusted in two parts:
PART 1 is a crossectional study in which the prevalance, risk factors and etiology of nocturia among postmenopausal women is assessed.
PART 2 is a cohort study observing the impact of 10 different hormonal substitution therapies on nocturia.
- Conditions
- Nocturia
- Being tested
- Questionnaire
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
All women fulfilled 3 questionairres
- TANGO
- ICIQ -N
- Perceived Stress Scale
| Study group | Role | What they receive |
|---|---|---|
| Oral estrogen + IUD | Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD Receives: Other: Questionnaire | |
| Oral estrogen + hysterectomy | Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy. Receives: Other: Questionnaire | |
| Oral estrogen + oral progesterone | Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone. Receives: Other: Questionnaire | |
| Transdermal estrogen + IUD | Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD. Receives: Other: Questionnaire | |
| Transdermal estrogen + hysterectomy | Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy. Receives: Other: Questionnaire | |
| Transdermal estrogen + oral progesteron | Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron Receives: Other: Questionnaire | |
| SERM | Women who opt to be treated for their postmenopausal symptoms using SERM's Receives: Other: Questionnaire | |
| Aromatase inhibitor | Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor. Receives: Other: Questionnaire | |
| Duavive | Women who opt to be treated for their postmenopausal symptoms using duavive. Receives: Other: Questionnaire | |
| No treatment | Women who opt not to be treated for their postmenopausal symptoms. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nocturnal Frequency
Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire
Measured: 6 months after initiating therapy
Secondary outcomes (1)
Change in bother linked with nocturnal frequency
Change in VAS scale of bother linked with nocturnal frequency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jun 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433897
- Sponsor's protocol ID
- EC 2018/0315 (BC-02592)
- Acronym
- HARALD
- Status last verified
- Apr 2024
- First submitted
- 12 Jun 2020
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observing the Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04433897
- Acronym / sponsor ID
- HARALD / EC 2018/0315 (BC-02592)
- Conditions
- Nocturia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of this study was to observe
The study was adjusted in two parts:
PART 1 is a crossectional study in which the prevalance, risk factors and etiology of nocturia among postmenopausal women is assessed.
PART 2 is a cohort study observing the impact of 10 different hormonal substitution therapies on nocturia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Oral estrogen + IUD | – | Other: QuestionnaireWomen who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD |
| Oral estrogen + hysterectomy | – | Other: QuestionnaireWomen who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy. |
| Oral estrogen + oral progesterone | – | Other: QuestionnaireWomen who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone. |
| Transdermal estrogen + IUD | – | Other: QuestionnaireWomen who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD. |
| Transdermal estrogen + hysterectomy | – | Other: QuestionnaireWomen who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy. |
| Transdermal estrogen + oral progesteron | – | Other: QuestionnaireWomen who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron |
| SERM | – | Other: QuestionnaireWomen who opt to be treated for their postmenopausal symptoms using SERM's |
| Aromatase inhibitor | – | Other: QuestionnaireWomen who opt to be treated for their postmenopausal symptoms using aromatase inhibitor. |
| Duavive | – | Other: QuestionnaireWomen who opt to be treated for their postmenopausal symptoms using duavive. |
| No treatment | – | Other: QuestionnaireWomen who opt not to be treated for their postmenopausal symptoms. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are biochochemically confirmed to be postmenopausal.
Key inclusion criteria (2 listed)
- Women with postmenopausal symptoms (hot flushes, atrophy, ..)
- All women were 'early' postmenopausal stages +1a,+1b or +1c as defined by the 'Stages of Reproductive Aging Workshop' (STRAW) criteria
Key exclusion criteria (5 listed)
- Intake of HRT on the moment of inclusion
- women with thyroid dysfunction
- women using antihypertensive agents
- women with a history of psychiatric or neurological disorders
- women with a history of alcohol or drug addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAll women fulfilled 3 questionairres * TANGO * ICIQ -N * Perceived Stress Scale | Other | Aromatase inhibitor, Duavive, No treatment, Oral estrogen + IUD, Oral estrogen + hysterectomy, Oral estrogen + oral progesterone, SERM, Transdermal estrogen + IUD, Transdermal estrogen + hysterectomy, Transdermal estrogen + oral progesteron |
Primary outcome
Change in nocturnal Frequency
Time frame: 6 months after initiating therapy
Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire
1 secondary outcome
Change in bother linked with nocturnal frequency
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Everaert contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturia, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Pauwaert (093321182, kim.pauwaert@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nocturnal Frequency (time frame: 6 months after initiating therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.